Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers

Trial Information

Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers

Inclusion Criteria:

- Healthy volunteers:

- males, >/=50 and = 65 years of age

- Cancer patients:

- males >/= 45 years of age

- Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT
for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary
prostate cancer patients) of recurrence prostate cancer and the primary cancer
disease is/ will be histologically confirmed.

- The prostate cancer is histologically confirmed and results of histology are
available.

- Patients with primary prostate cancer: >/= 20 percent of biopsy material should
be affected by cancer in the histopathological evaluation.

Study ID:

NCT ID:

Start Date:

Completion Date:

Related Keywords:

Name

Location

We are a Cancer Social Network, Resource Directory & Education Hub supporting all those affected by cancer. knowcancer.com is intended to be solely for informational purposes and should not be a substitute for professional medical advice, diagnosis or treatment.